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Last Updated: October 27, 2020

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CLINICAL TRIALS PROFILE FOR BELANTAMAB

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All Clinical Trials for belantamab

Trial ID Title Status Sponsor Phase Start Date Summary
NCT04091126 Bortezomib, Lenalidomide and Dexamethasone (VRd) With Belantamab Mafodotin Versus VRd Alone in Transplant Ineligible Multiple Myeloma Not yet recruiting GlaxoSmithKline Phase 3 2019-12-18 This study will evaluate the efficacy and safety of belantamab mafodotin in combination with VRd compared with VRd alone in adult participants with transplant ineligible (TI) newly diagnosed multiple myeloma (NDMM). The study will consist of 2 parts: part 1 will evaluate the safety and tolerability of different doses/dosing regimens of belantamab mafodotin in combination with VRd in an escalating manner and will determine the recommended phase 3 dose (RP3D). Part 2 will evaluate the efficacy and safety of the selected RP3D of belantamab mafodotin in combination with VRd compared with VRd alone.
NCT04126200 Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 5) Recruiting GlaxoSmithKline Phase 2 2019-10-07 B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with multiple myeloma. Belantamab mafodotin (GSK2857916); also referred to as GSK'916; is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized, open-label, platform study designed to evaluate the effects of GSK'916 (belantamab mafodotin) in combination with other anti-cancer drugs in participants with relapsed/refractory multiple myeloma (RRMM). The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously. This study will include two parts; dose exploration (DE) and cohort expansion (CE). In the DE phase, the safety and tolerability profile of GSK'916 (belantamab mafodotin) will be evaluated when administered in combination with other anti-cancer agents. This may identify a recommended phase 2 dose (RP2D) for each partner, as well as efficacy of each combination. The CE phase of the study will evaluate the clinical activity of the combinations in comparison to monotherapy in additional participants with RRMM. Approximately 85 participants will be enrolled across both the DE and CE phases of each sub-study.
NCT04162210 Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) Not yet recruiting GlaxoSmithKline Phase 3 2019-12-05 This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered intravenously at 2.5 milligram (mg)/kilogram (kg) on Day 1 (D1) of an every 3 weeks (Q3W) schedule. Pomalidomide will be administered orally at the approved starting dose of 4 mg daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered orally at a dose of 40 mg once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first. Approximately 380 participants will be randomized.
NCT04177823 A Study of Belantamab Mafodotin to Investigate Safety, Tolerability, Pharmacokinetics, Immunogenicity and Clinical Activity in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) Not yet recruiting GlaxoSmithKline Phase 1 2019-12-23 Multiple myeloma (MM) is a neoplastic plasma cell disorder that is characterized by osteolytic bone lesions, anemia, hypercalcemia and renal failure. belantamab mafodotin was well tolerated in previous studies with at least one dose of belantamab mafodotin in heavily pre-treated participants with relapsed/refractory multiple myeloma (RRMM). This aim of the study is to explore safety, pharmacokinetics (PK), tolerability, immunogenicity and clinical activity of belantamab mafodotin monotherapy in Chinese participants with RRMM who have received at least 2 prior line of anti-myeloma therapy including an alkylator, a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD). This study will include two dose cohorts 2.5 milligram per kilogram (mg/kg) and 3.4 mg/kg. A maximum of 12 participants will be enrolled, 6 each for 2.5 mg/kg cohort and 3.4 mg/kg cohort based on 3+3 design. Participants will be treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
NCT04246047 Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma Not yet recruiting GlaxoSmithKline Phase 3 2020-04-09 This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.
NCT04398680 A Study of Belantamab Mafodotin (GSK2857916) in Multiple Myeloma Participants With Normal and Impaired Hepatic Function Not yet recruiting GlaxoSmithKline Phase 1 2020-07-30 Belantamab mafodotin (GSK2857916) is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Impaired hepatic function may alter the pharmacokinetics (PK) and pharmacodynamics (PD) of belantamab mafodotin, a drug that is primarily hepatically eliminated and hence may require adjustments in dosing regimens as compared to patients who have normal hepatic function. The purpose of this study is assess the PK, safety, and tolerability of belantamab mafodotin monotherapy in Relapsed/Refractory Multiple Myeloma (RRMM) participants with impaired hepatic function and in matched RRMM participants with normal hepatic function. The study will consist of two parts: Part 1 will include participants with normal hepatic function and moderate hepatic impairment and Part 2 will include participants with severe hepatic impairment. Participants will be administered GSK2857916 at a dose of 2.5 milligram per kilogram (mg/kg) intravenously in Part 1 and in Part 2, dose will depend on the evaluation of pharmacokinetic and safety data of Part 1. However, dose in Part 2 will not exceed 2.5 mg/kg. Participants will be treated with GSK2857916 monotherapy until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. This study will include a screening phase, treatment phase and follow-up phase. The total duration of the study is approximately up to 48 months.
NCT04398745 A Study of Belantamab Mafodotin (GSK2857916) in Multiple Myeloma Participants With Normal and Impaired Renal Function Not yet recruiting GlaxoSmithKline Phase 1 2020-07-30 Belantamab mafodotin (GSK2857916) is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Renal impairment is a major complication of multiple myeloma (MM) and majority of MM participants either are at risk or already have renal dysfunction at initial diagnosis. The purpose of this study is assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment and have either normal or impaired renal functions. The study will consist of two parts: part 1 will include participants with normal renal function and severe renal impairment and part 2 will include participants with end-stage renal disease (ESRD) where participants are either not undergoing or require hemodialysis. Participants will be administered GSK2857916 at a dose of 2.5 milligram per kilogram (mg/kg) intravenously in Part 1 and in Part 2, dose will depend on the evaluation of pharmacokinetic and safety data of Part 1. However, dose in Part 2 will not exceed 2.5 mg/kg. Participants will be treated with GSK2857916 monotherapy until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. This study will include a screening phase, treatment phase, and follow-up phase. The total duration of the study is approximately up to 48 months.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for belantamab

Condition Name

Condition Name for belantamab
Intervention Trials
Multiple Myeloma 9
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Condition MeSH

Condition MeSH for belantamab
Intervention Trials
Multiple Myeloma 9
Neoplasms, Plasma Cell 8
Renal Insufficiency 1
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Clinical Trial Locations for belantamab

Trials by Country

Trials by Country for belantamab
Location Trials
China 2
Australia 1
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Clinical Trial Progress for belantamab

Clinical Trial Phase

Clinical Trial Phase for belantamab
Clinical Trial Phase Trials
Phase 3 5
Phase 2 1
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for belantamab
Clinical Trial Phase Trials
Not yet recruiting 8
Recruiting 1
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Clinical Trial Sponsors for belantamab

Sponsor Name

Sponsor Name for belantamab
Sponsor Trials
GlaxoSmithKline 9
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Sponsor Type

Sponsor Type for belantamab
Sponsor Trials
Industry 9
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